论文部分内容阅读
目的:综合评价参麦注射液上市后的安全性,探索中药注射液上市后安全性再评价的方法和模式。方法:以2011年1-11月医院应用参麦注射液的住院患者为研究对象,从用药开始至出院,观察记录患者的药品使用和不良反应发生情况,并进行数据统计分析。结果:699例患者中,发生不良反应5例,发生率为0.72%。结论:参麦注射液的不良反应发生率较低,但临床使用欠规范,应进一步规范中药注射液在临床中的使用。
OBJECTIVE: To evaluate the safety of Shenmai injection on the market and to explore the methods and models for safety re-evaluation after the listing of TCM injection. Methods: From January to November 2011, inpatients with Shenmai injection in hospital were selected as research objects. Drug use and adverse reactions were observed and recorded from the beginning of medication to the next, and the data were analyzed statistically. Results: Among 699 patients, 5 cases occurred adverse reactions, the incidence was 0.72%. Conclusion: The incidence of adverse reactions of Shenmai injection is low, but the clinical use is not standardized, and the use of traditional Chinese medicine injections should be further standardized.